Intervention to Improve Follow-up of Abnormal Pap Test
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Active control
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer focused on measuring unified theory of behavior, Pap test, cervical dysplasia, women's health
Eligibility Criteria
Inclusion Criteria:
- Women aged 18 to 55 years who present to the University of Texas Medical Branch (UTMB) clinics for Pap testing.
Exclusion Criteria:
- Women who are currently pregnant
- Have a current diagnosis of cervical cancer; or
- Who are unable to understand English or Spanish.
Sites / Locations
- University of Texas Medical Branch
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Intervention
Active Control
Standard Care Only
Arm Description
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Clinical standard of care at time of study
Outcomes
Primary Outcome Measures
Adherence to Initial Follow-up (Yes/no)
Attendance at initial appointment to follow-up abnormal Pap test result
Secondary Outcome Measures
State Trait Anxiety Inventory (STAI)-State Scale
State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)
Full Information
NCT ID
NCT00575510
First Posted
December 14, 2007
Last Updated
July 25, 2018
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00575510
Brief Title
Intervention to Improve Follow-up of Abnormal Pap Test
Official Title
Intervention to Improve Follow-up of Abnormal Pap Test
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project will examine whether a theory-based telephone intervention delivered by a nurse at the time women are informed of an abnormal Pap test result will increase adherence to follow-up recommendations.
Detailed Description
Over 90% of deaths due to cervical cancer could be prevented with appropriate screening and treatment of precursor lesions. However, 20% to 70% of women in the United States who are told that their Papanicolaou (Pap) test was abnormal do not adhere to recommendations for follow-up care. This is a problem especially among minorities and women of lower socioeconomic status. The purpose of this part of the protocol is to test a theory-based intervention designed to improve adherence to follow-up among women who experience an abnormal Pap test. The intervention is a message, delivered over the telephone by a nurse, at the time Pap test results are given to patients. The investigators propose to randomize women who experience an abnormal Pap test to one of three groups: (1) targeted cultural belief + knowledge + importance message (intervention), (2) nontargeted belief + knowledge + importance (active control), or (3) standard care only (passive control). All three groups will receive standard care, which is to notify women by telephone of their abnormal results and provide instructions for follow-up. Women assigned to the intervention group also will receive a cultural belief component consistent with their racial/ethnic group, detailed information about follow-up procedures and the consequences of not returning for follow-up, and information regarding the importance of adhering to recommendations, particularly for "low grade" abnormalities. Women assigned to the active control group will receive a nontargeted belief component, plus procedural knowledge and a message on the importance of follow-up. Adherence to initial follow-up will be the primary outcome. Other behavioral outcomes, such as delayed care and completeness of care, also will be assessed over an 18-month interval by chart review. Additionally, the investigators will evaluate psychological outcomes including anxiety and distress. Finally, the investigators will examine the grade of abnormality (low versus high) as an effect modifier. The investigators anticipate that this research will result in an intervention that will improve several important behavioral and psychological outcomes related to abnormal Pap test results. The intervention is guided by a general integrative theoretical framework; therefore, this research will evaluate an intervention strategy that recognizes the importance of targeting culturally relevant beliefs about follow-up and key determinants of behavior (knowledge/skills, salience, environmental constraints) surrounding abnormal Pap test results. Ultimately, the objective of this research is to improve adherence to follow-up among low-income, minority women who are at particular risk of developing cervical cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
unified theory of behavior, Pap test, cervical dysplasia, women's health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
341 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Arm Title
Standard Care Only
Arm Type
No Intervention
Arm Description
Clinical standard of care at time of study
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Multiple component intervention based in the unified theory of behavior
Intervention Type
Behavioral
Intervention Name(s)
Active control
Intervention Description
Partial intervention (full intervention minus cultural-specific component)
Primary Outcome Measure Information:
Title
Adherence to Initial Follow-up (Yes/no)
Description
Attendance at initial appointment to follow-up abnormal Pap test result
Time Frame
adherence rates at initial follow-up appointment, 2 weeks to 3 months
Secondary Outcome Measure Information:
Title
State Trait Anxiety Inventory (STAI)-State Scale
Description
State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)
Time Frame
+ 7-30 days post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women aged 18 to 55 years who present to the University of Texas Medical Branch (UTMB) clinics for Pap testing.
Exclusion Criteria:
Women who are currently pregnant
Have a current diagnosis of cervical cancer; or
Who are unable to understand English or Spanish.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen R Breitkopf, PhD
Organizational Affiliation
University of Texas Medical Branch, Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23730719
Citation
Breitkopf CR, Dawson L, Grady JJ, Breitkopf DM, Nelson-Becker C, Snyder RR. Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial. Health Psychol. 2014 Apr;33(4):307-316. doi: 10.1037/a0032722. Epub 2013 Jun 3.
Results Reference
result
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Intervention to Improve Follow-up of Abnormal Pap Test
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